On 17 July 2015 Russian Ministry of Health will enforce the Decree #303 dated from 3 June 2015 (link in Russian) which implements some quite significant changes in the procedure of expertise of medical devices in Russia for its registration:
- Class 1 medical devices submitted for registration after this day will pass only through second phase of quality and safety expertise for approval – for these products first phase of expertise will be excluded from the registration procedure, what will make full process shorter and easier. Instead, for the simplified procedure Roszdravnadzor recommends submitting in the registration dossier documents conforming clinical efficiency and safety (clinical reports and literature review).
- On the other hand procedure for changes and amendments of instruction for use and technical file for medical devices which are already registered in Russia became more complicated. Starting from 17 July 2015, in order to obtain approval from Roszdravnadzor for such changes (according to clause 55 of medical device registration Rules, Decree 1416, link in Russian), dossier should pass through expertise phase (similar with registration expertise). From practical standpoint that means that for such changes costs and approval lead-time increase can be expected.